Cadrenal Therapeutics FY Conference Summary Company Overview - **Company**: Cadrenal Therapeutics (Ticker: CVKD) - **Focus**: Bridging critical gaps in anticoagulation for rare and high-risk patients, particularly those with end-stage renal disease (ESKD) and atrial fibrillation (AFib) [3][4] Core Programs 1. **Tecarfarin**: - Phase 3 program targeting kidney-impaired patients with AFib and those with implanted left ventricular assist devices (LVADs) - Orphan drug designation received for ESKD and AFib [4][5] 2. **VLX-1005**: - Acquired from Verilux, recently completed Phase 2 trials for Heparin-Induced Thrombocytopenia (HIT) - Received Orphan and Fast Track designations [5][6][14] 3. **Fruinexian**: - Short-acting Factor XI candidate acquired in Fall 2025, aimed at cardiovascular surgery [5][6] Market Context - **Anticoagulation Landscape**: - Direct Oral Anticoagulants (DOACs) have dominated the market since their introduction, but gaps remain for patients who cannot use them, such as those with mechanical heart valves and LVADs [4][5] - Warfarin, a vitamin K antagonist, is still widely used despite its limitations, particularly in patients with kidney issues [4][5] Regulatory Advantages - **Orphan Drug and Fast Track Designations**: - These designations allow for smaller, more flexible trials, tax credits, fee waivers, and market exclusivity, reducing development costs and risks [21][22] - Fast Track designation enables earlier FDA interactions and rolling submissions [21][22] Unmet Needs and Market Opportunity - **HIT Market**: - Approximately 50,000 new HIT patients are confirmed annually in the U.S., indicating a significant unmet need for effective treatments that do not exacerbate bleeding risks [19][20] - Current treatments are often ineffective, leading to high morbidity and mortality rates [14][19] Future Outlook - **Long-term Strategy**: - Cadrenal aims to provide alternatives to long-standing anticoagulants like warfarin and heparin, particularly for patients with specific needs [25][27] - The company is excited about the potential for oral applications of 12-LOX inhibitors for chronic conditions [32] Key Milestones - **Upcoming Developments**: - Analysis and publication of VLX-1005 Phase 2 data - Ongoing interactions with the FDA for both VLX-1005 and tecarfarin [30][31] Conclusion - **Vision for Impact**: - In five years, Cadrenal aims to be recognized for addressing the needs of patients with HIT, ESKD, and advanced mechanical heart valves, providing effective therapeutic options where larger pharmaceutical companies have not ventured [32]

Core Insights - Cadrenal Therapeutics is addressing the unmet medical need in heparin-induced thrombocytopenia (HIT) with its investigational drug candidate VLX-1005, which is the first and only potent, highly selective 12-LOX inhibitor in clinical testing [1][3][10] Company Developments - Cadrenal acquired VLX-1005 in December 2025, recognizing its potential to transform treatment for HIT and other immune-mediated thrombotic disorders [2] - The company is rapidly engaging with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT [9] Clinical Insights - Emerging data from a Phase 2 clinical trial suggest that VLX-1005 may reduce thrombotic complications, indicating its potential as a novel therapy that targets immune thrombotic drivers rather than just suppressing coagulation [3][4] - Recent findings highlight the high incidence and clinical burden of thrombotic complications in HIT, emphasizing the limitations of existing therapies that do not directly modulate platelet immune responses [5] Scientific Background - 12-lipoxygenase (12-LOX) has been identified as a key mediator of platelet activation and immune thrombotic responses, making it a compelling therapeutic target [6] - VLX-1005 is designed to selectively modulate immune-mediated platelet activation while minimizing off-target effects, representing a significant advancement in the development of 12-LOX inhibitors [8] Regulatory Status - VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the FDA, as well as orphan drug status from the European Medicines Agency [10]

Core Insights - Some companies enter a market due to perceived opportunities, while others do so to address unsustainable situations that require resolution [1] Group 1 - Companies are motivated by either opportunity or the need to fix unsustainable market conditions [1]

Core Insights - The article highlights the overlooked areas within the anticoagulation industry, suggesting that these neglected segments have developed into significant markets [1] Industry Overview - The anticoagulation sector is characterized by various underexplored niches that have the potential for growth and innovation [1]

Core Insights - Cadrenal Therapeutics, Inc. is focused on developing transformative therapeutics to address limitations in current anticoagulation therapy, particularly for rare and high-risk patient populations [1][2] Company Overview - Cadrenal Therapeutics is engaged in the $40 billion anticoagulation market, aiming to bridge critical gaps in acute and chronic anticoagulation management [2] - The company has three clinical-stage assets: - VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with heparin-induced thrombocytopenia (HIT) [4][6] - Tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), currently Phase 3-ready [4][6] - Frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings, currently Phase 2-ready [4][6] Upcoming Events - The management team, including CEO Quang X. Pham, will hold partnering and investor meetings during the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, CA [1][2] Strategic Focus - The company aims to develop novel, differentiated products that address significant gaps in anticoagulation management for specific patient populations [2][4]

Core Insights - Cadrenal Therapeutics is strategically building its foundation with a focus on execution rather than hype, making significant progress in trial preparations, manufacturing, and leadership expansion [1][3][7] Drug Development - Tecarfarin, a key drug candidate, targets a clinically neglected segment of anticoagulation for high-risk patients with end-stage kidney disease and complex cardiac issues, aiming to provide better control, reversibility, and stability [2][10] - The addition of the Factor XIa program enhances Cadrenal's portfolio, allowing entry into acute hospital care, which complements tecarfarin's chronic care focus [4][8] - The acquisition of VLX-1005, a Phase 2 asset for heparin-induced thrombocytopenia (HIT), is a strategic move that positions Cadrenal in discussions that were previously unavailable, given its regulatory designations [5][10] Market Positioning - Despite the company's advancements, the stock continues to trade as if no changes have occurred, indicating a potential disconnect between market perception and the company's actual progress [6][9] - The structured portfolio is designed to create leverage, with each asset reinforcing the others and presenting a coherent vision rather than a disjointed pipeline [8] Future Outlook - Cadrenal is entering a phase where its groundwork could lead to visible catalysts, with trial preparations and regulatory engagements becoming increasingly significant [7][9] - The company is poised to transition from a quiet phase to one where its data-driven achievements will gain market attention, suggesting a readiness to assert its presence [9]

Core Viewpoint - Cadrenal Therapeutics is positioned in a niche market that is significantly underserved, focusing on developing innovative anticoagulants for difficult-to-treat patient populations, particularly those with end-stage kidney disease and atrial fibrillation [1][2]. Company Developments - The company has made strides in manufacturing readiness, enhanced its leadership team, and expanded its pipeline, notably through the acquisition of VLX-1005, a Phase 2 program for Heparin-Induced Thrombocytopenia (HIT), which is expected to enhance its strategic position [3][5]. - Cadrenal is transitioning from a single-asset microcap to a multi-faceted clinical platform within the $40 billion anticoagulation market, with the Factor XIa portfolio opening opportunities in acute hospital settings [4][6]. Market Position and Valuation - Despite the expansion of its portfolio, the market continues to undervalue Cadrenal, treating it as a single-asset company rather than recognizing its diverse clinical approaches and potential catalysts [6][7]. - The company is on the verge of significant milestones, with tecarfarin nearing Phase 3 trial readiness and VLX-1005 entering a critical phase for clinical data, which could lead to a reevaluation of its market position [8][9]. Future Outlook - The current period may be the last opportunity for investors to underestimate Cadrenal, as the company is preparing for impactful milestones that could shift market perception from overlooked to obvious [9].

Core Insights - Cadrenal Therapeutics has acquired VLX-1005 and related 12-LOX assets from Veralox Therapeutics, enhancing its pipeline with a late-stage drug candidate aimed at the $40 billion global anticoagulation market [1][4] Company Overview - Cadrenal Therapeutics is focused on developing innovative therapeutics to address gaps in anticoagulation management for high-risk patient populations, with three clinical-stage assets including VLX-1005, tecarfarin, and frunexian [6] Product Details - VLX-1005 is a selective small-molecule inhibitor of 12-LOX, targeting immune platelet-mediated inflammation and addressing heparin-induced thrombocytopenia (HIT), which affects up to 5% of patients exposed to heparin [2][8] - The drug has received Orphan Drug Designation and Fast Track designation from the FDA, indicating its potential significance in treating rare conditions [4][8] Clinical Development - Phase 1 studies of VLX-1005 showed it was well tolerated with no serious adverse events, while a Phase 2 study indicated promising reductions in thromboembolic events among patients with suspected HIT [3][4] - The market for HIT treatment is estimated to reach $1 billion in the US and EU, highlighting the commercial potential of VLX-1005 [5] Acquisition Terms - The acquisition agreement includes upfront and milestone payments to Veralox contingent on future clinical and regulatory achievements, as well as royalties on global sales of VLX-1005 [5]

Core Insights - Cadrenal Therapeutics, Inc. has appointed Dr. Lee Scott Golden as an independent director to its Board of Directors, effective immediately [1][3] - Dr. Golden brings over 25 years of experience in the biopharmaceutical industry, particularly in cardiovascular medicine and anticoagulation therapy [2][3] - The company aims to develop novel anticoagulants to address significant unmet needs in both acute and chronic anticoagulation therapy [4] Company Overview - Cadrenal Therapeutics focuses on developing innovative biopharmaceutical products that improve anticoagulation therapy by providing greater predictability, stability, and fewer bleeding complications [4] - The company currently has two clinical-stage assets: tecarfarin, an oral vitamin K antagonist for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings [4] - The mission is to reshape standards of care in anticoagulation by targeting underserved patient populations [4]

Core Insights - Cadrenal Therapeutics, Inc. has been recognized for its leadership in the biopharmaceutical sector, particularly in anticoagulation therapy, with CEO Quang X. Pham receiving the "Executive of the Year Award" from BioFlorida [1][3] Company Overview - Cadrenal Therapeutics is focused on developing innovative biopharmaceutical products aimed at addressing significant gaps in both acute and chronic anticoagulation therapy [4] - The company is advancing two clinical-stage assets: tecarfarin, an oral vitamin K antagonist for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings [4] - Cadrenal aims to reshape standards of care in anticoagulation by targeting underserved patient populations and enhancing the predictability, stability, and control of anticoagulant therapies [4] Industry Context - BioFlorida represents a broad spectrum of organizations within Florida's life-science ecosystem, including biotechnology and medical technology, and is dedicated to fostering innovation and economic growth in the sector [2]